Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1089-2013 — LHB, Perishable Items Pack Type I , Kit Number: 2114002-100. First Aid Kit.

U.S. FDA — Device Enforcement · United States · 2013-03-22 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1089-2013
Date of alert
2013-03-22
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Lighthouse For The Blind
Product category
device
Product type
Devices
Reported risk: The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm's distributor. The labeling of the iodine 10% Ampule labels state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterili
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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